Antibiotic paper trail sought

Jul 13, 2012

In the latest of a series of increasing demands on the Food and Drug Administration (FDA) to reexamine its approval of antibiotics for subtherapeutic use in livestock, a non-profit group has sued the agency, saying that their requests for public disclosure of documents about antibiotic policy were ignored.

The plaintiff in the case is PEER (Public Employees for Environmental Responsibility), a nonprofit environmental organization that supports whistle-blowing claims leveled against government agencies by disaffected employees. PEER alleges that FDA failed to respond to two separate requests for documents under the Freedom of Information Act (FOIA): one seeking documentation of FDA’s issuing “categorical exclusions” to exempt some antibiotics from environmental analysis, and another requesting information supporting FDA’s decision to reduce levels of antibiotics being fed to livestock by encouraging the voluntary cooperation of pharmaceutical companies and producers, as opposed to issuing mandatory regulations.

In a press release, New England PEER Director Kyla Bennett, a biologist and attorney formerly with the U.S. Environmental Protection Agency, complained that FDA has turned a blind eye on potential fallout from the widespread practice of feeding livestock low doses of antibiotics for disease prevention and weight gain.

“FDA …does not even consider the post-dosage effects of these livestock drugs, most of which are not metabolized by the animal and remain in the tidal wave of livestock waste flowing from factory farms,” Bennet stated. “These chemicals make their way into our rivers and lakes where effects on wildlife are already being seen. Not surprisingly, these drugs are now present in the drinking water of nearly 50 million Americans.”

PEER’s complaint was filed July 3 in Washington, D.C., Federal District Court.

This latest action comes on the heels of an unrelated case in which FDA was sued by the non-profit group Natural Resources Defense Council (NRCD) along with four other organizations–the Union of Concerned Scientists, the Center for Science in the Public Interest, the Food Animal Concerns Trust, and Public Citizen. The case centered on a 1977 notice from FDA which called for withdrawal of penicillin and tetracycline in livestock feed because of a potential human health threat. The notice was never acted on, despite the fact that numerous drug companies requested hearings to demonstrate that the drugs were safe. Now, critics argue that the practice releases large quantities of drugs into human water supplies, and can promote the growth of antibiotic resistant superbugs, weakening the drugs’ effectiveness in humans.

Magistrate Judge Theodore Katz of the Southern New York District Federal District Court ruled in favor of NRCD, requiring FDA to initiate withdrawal proceedings for penicillin and tetracycline. Katz further ruled in June on a separate complaint of NRDC’s, requiring FDA to initiate scientific reviews for all antibiotics used for non-therapeutic treatment of livestock.

Although FDA released final guidance in April recommending a voluntary approach to reducing nontherapeutic antibiotic use in livestock, Katz ruled the guidance was less than adequate, and skirted the agency’s responsibility to scientifically study and withdraw potentially harmful drugs.

“[I]f an approved drug is not shown to be safe or effective, the Agency must begin withdrawal proceedings,” wrote Katz. “The Agency has forsaken these obligations in the name of a proposed voluntary program … and acted contrary to the statutory language.”

PEER’s recent complaint adds to the spotlight of scrutiny now being trained on FDA’s procedures for approving antibiotics for sub- and non-therapeutic uses. In November of last year, PEER submitted a FOIA request to FDA calling for public release of all documents pertaining to the agency’s decision to categorically exclude certain antibiotics approved for animals from the environmental analysis typically required under the National Environmental Policy Act. A categorical exclusion is issued only when an action is known not to have a significant impact on the human environment. Although an acknowledgement was sent to PEER from FDA verifying that the request had been received, no documents were released in the intervening eight months, according to PEER’s complaint.

According to PEER, although FDA did release documents in response to a second FOIA request in January calling for information supporting FDA’s voluntary approach to reducing antibiotics, the documents released were not relevant.

Attorney Katheryn Douglass, who filed the complaint for PEER, attributed FDA’s reluctance to evaluate the safety of antibiotics on food animals to livestock industry power politics.

“Nearly 40 years ago, FDA itself first raised the alarm about antibacterial resistance from mega-dosing of livestock,” Douglass said in a statement. “Unfortunately since then, through Congressional intervention or the threat thereof, industry has kept FDA cowed.”

Kathy Simmons, D.V.M. and chief veterinarian for the National Cattlemen’s Beef Association, does not agree. Simmons suggested that a voluntary approach to managing antibiotic use was the most effective way for FDA to address concerns about antibiotic use while not becoming overwhelmed by new research and hearings triggered by litigation.

“The industry believes in science-based standards,” explained Simmons. “We always have. We certainly want the science to come to light. But I think the negatives here are the resources and time the FDA is going to have to put towards a process that we think is already accurately in place.”

Simmons added that the industry already has quality assurance standards and guidelines to ensure that antibiotics are used sensibly and safely.

“We … remain committed to the judicious use of antibiotics,” explained Simmons. “We always have within the beef industry.” — Andy Rieber, WLJ Correspondent